# K233013: 2-Way 100% Silicone Cleartract Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Silq Technologies Corporation
- Decided: Jan 23, 2024 after 123 days
- Product code: EZL (Catheter, Retention Type, Balloon)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K984084 (1999). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222118: 2-Way 100% Silicone Cleartract Catheter, Silq Technologies, Corp. (2022) Summary page 5.

## Indications for use
The 2-Way 100% Silicone ClearTract Catheter is intended for drainage of the urinary tract. Catheterization is accomplished by inserting the catheter through the urethra and into the bladder, but also suprapubic placement or by nephrostomy. Intended population is adults and pediatrics.

Source page: https://510kreport.com/device/K233013
Methodology: https://510kreport.com/methodology